R&D Quality Auditor (m/f/d)

As an R&D Quality Auditor at Elanco, you ensure compliance and quality across animal health development activities, partnering with global R&D teams. You implement Elanco Quality Standards, deliver training, and support GxP adherence through audits and oversight. You’ll review procedures, manage third-party quality agreements, and contribute to global quality compliance efforts. This role combines hands-on auditing with strategic quality input to enable regulatory submissions and product development at a global scale.

• Employer subsidised pension scheme
• 40 hours / week
• 30 days holiday + additional time off
• Active BGM and health care
• Subsidy for Deutschlandticket and bicycle leasing
• Meal allowance in canteens

• Provide quality oversight across R&D functions and global projects with stakeholder collaboration
• Plan and conduct GxP oversight activities (GRP, GCP, GLP) including study protocol reviews, in-life activities, data/reports audits, and site inspections
• Review SOPs and EFPs to ensure alignment with Elanco Quality Standards and regulatory requirements
• Deliver quality/compliance training on GxP topics to R&D personnel
• Maintain quality agreements with third parties and support EGQCA audits at external sites

• Degree in Science (MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences, or equivalent)
• Minimum 5 years of auditing experience in animal health studies
• Experience in QA oversight or monitoring of veterinary clinical studies for regulatory submissions
• Knowledge in GCP (VICH GL9) or OECD GLP
• Fluency in English; German or another EU language (Spanish/Portuguese)
• Ability to make decisions without clear right or wrong answers
• Experience creating/revising quality procedures and driving quality process rollout at a site

• Decision-making under ambiguity
• Strong collaboration with cross-functional teams
• Training and knowledge transfer abilities
• GxP oversight (GRP, GCP, GLP)
• Quality procedures development and rollout
• Auditing of veterinary clinical studies